【摘要】 目的通过对CREDITⅡ、Ⅲ研究中的糖尿病亚组资料进行分析,探讨第二代聚合物涂层可降解钴铬合金西罗莫司(雷帕霉素)洗脱支架(EXCEL2)在糖尿病患者中的有效性和安全性。方法入选了CREDITⅡ、Ⅲ研究中置入EXCEL2支架的所有患者。主要终点为24个月的靶病变失败,以心源性死亡、靶血管心肌梗死和临床驱动的靶病变血运重建为复合终点。次要终点为患者相关复合终点,包括全因死亡、心肌梗死和血运重建。结果入选828例患者24个月随访率99.5%,糖尿病组与非糖尿病组比较,主要终点事件发生率(P>0.05)及次要终点发生率[全因死亡(2.5%比1.4%,P=0.290)、心肌梗死(7.5%比5.0%,P=0.215)、任何血运重建(5.0%比3.9%,P=0.533)以及支架内血栓形成(0.6%比0.5%,P=0.577)],差异均无统计学意义。结论 EXCEL2支架可降低糖尿病患者术后支架内再狭窄、靶病变血运重建率及支架内血栓形成风险,且不劣于非糖尿病患者。更多还原

【Abstract】 Objective To invesgate the safety and efficacy of the second generation biodegradable polymer Cobalt-Chromium sirolimus-eluting stent(EXCEL2) stent in diabetic patients by a subgroup analysis of of the CREDIT Ⅱ and CREDIT Ⅲ trials. Methods All patients who were implanted with the EXCEL2 stent were enrolled in the CREDIT Ⅱ and CREDIT Ⅲ trials. The primary endpoint was target lesion failure at 24-month, defi ned as a composite of cardiac death, target vessel myocardial infarction(TV-MI) and target lesion revascularization(TLR). The secondary endpoint was endpoints including all-cause death, all myocardial infarction(MI) or any revascularization.Results A total of 828 patients were included from the patients who were implanted with the EXCEL2 stent in the CREDIT II and CREDIT Ⅲ trials. 24-month follow-up rate was 99.5%. There was no significant difference in the primary endpoint(P>0.05) and event rates of the secondary endpoints(P>0.05) between the diabetic and non-diabetic group, which included all-cause death[diabetics(2.5%) vs. non-diabetics(1.4%), P>0.05], myocardial infarction(MI)(7.5% vs. 5.0%,P>0.05), all from of revascularization(5.0% vs. 3.9%,P>0.05), and stent thrombosis(0.6% vs. 0.4%,P>0.05).Conclusions EXCEL 2 stent met the objective performance goal on efficacy and safety, which can reduce make stent restenosis, target vessel revascularization,with 160 diabetic cases among them, and stent thrombosis in diabetic patients.更多还原